Quality Control (QC) devices and methods have become an increasingly important part of healthcare over the last few decades. Specifically in healthcare, QC has traditionally occurred at the site of the manufacturer, as opposed to the point of use. However, with the development of new contrast agents and other short half-life pharmaceutical products, it may be necessary to perform compounding or processing steps immediately prior to administration into a patient. Prior to injection, the safety and efficacy of the substance should be ensured. As such, Quality Control is important for radio-synthesized Positron Emission Tomography (PET) tracers that are to be used in clinical and research circumstances. The QC of radiotracers generally involves manual execution and subjective analysis in tests such as color and appearance, pH, radioactivity concentration, radiochemical purity, etc.
The quality requirements for radiotracers are set out in various pharmacopoeia including United States Pharmacopeia (USP), British Pharmacopeia (BP), European Pharmacopeia (EP), etc. It should be noted that the quality control requirements of various radiotracers differ among different countries as different countries may adopt a different set of standards.